MAUDE Adverse Event Report: NOVO NORDISK A/S, MEDICAL SYSTEMS NOVOPEN 4; INSULIN DELIVERY DEVICE

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Hypoglycemia (1912)

Event Date 04/13/2019

Event Type  Injury  

Event Description

Event verbatim [preferred term] (related symptoms if any separated by commas).Very low sugar level [blood glucose decreased].Novopen 4 is not working properly [device malfunction].High blood sugar [blood glucose increased].Irregular blood sugar levels [blood glucose abnormal].Case description: this serious spontaneous case from portugal was reported by a other caregiver as "very low sugar level" beginning on (b)(6) 2019, "novopen 4 is not working properly" with an unspecified onset date, "high blood sugar" with an unspecified onset date, "irregular blood sugar levels" beginning on (b)(6) 2019, and concerned a (b)(6) years old male patient who was treated with insulatard penfill (insulin human) from unknown start date and ongoing due to "diabetes mellitus" (regimen #1 dose and frequency 34u in the morning and 10u at night, regement #2 dose and frequency 20u in the morning and 10u at night ongoing), , novopen 4 (insulin delivery device) from unknown start date due to "diabetes".(b)(6).Medical history included diabetes mellitus (type and duration: not reported).Since an unknown date novopen 4 was not working properly.On (b)(6) 2019 patient had irregular blood sugar levels.And was hospitalized due to low blood sugar of (35 mg/dl).Patient recovered and was released from hospital on (b)(6) 2019 (in the morning he had a blood sugar level of 170 mg/dl).Before the hospitalization event he was administering 34u of insulatard penfill in the morning and 10u at night.When the patient was released from the hospital, the doctor reduced the morning dose to 20u.And the patient experienced high blood sugar with value reported to be 370 mg/dl.Action taken to insulatard penfill was reported as dose decreased.Action taken to novopen 4 was not reported.Batch numbers were requested.The outcome for the event "very low sugar level" was recovered.The outcome for the event "novopen 4 is not working properly" was not reported.The outcome for the event "high blood sugar" was not reported.The outcome for the event "irregular blood sugar levels" was not yet recovered.

Event Description

Case description: investigation results novopen® 4 silver - batch unknown.No investigation was possible, because neither sample nor batch number was available.Insulatard® penfill® 100 ui/ml 3 ml - batch unknown no investigation was possible, because neither sample nor batch number was available.Since last submission the case has been updated with following.Laboratory data updated.Operator of device updated.Investigation results updated.Narrative updated accordingly.Manufacturer's comment updated.Manufacturer's comment: 27-may-2019: as the device (novopen 4) has not been returned to novo nordisk a/s for investigation and only very limited information regarding the handling of suspected device is available, it is not possible to identify a clear root-cause of the experienced adverse event and thus find similar incidents to the one reported in argus case 658643.The reported events are listed.This single case report is not considered to change the current knowledge of the safety profile of insulatard.Evaluation summary: novopen® 4 silver - batch unknown.No investigation was possible, because neither sample nor batch number was available.

• Brand Name: NOVOPEN 4
• Type of Device: INSULIN DELIVERY DEVICE
• Manufacturer (Section D): NOVO NORDISK A/S, MEDICAL SYSTEMS; hilleroed, ; DA
• MDR Report Key: 8616761
• MDR Text Key: 145486571
• Report Number: 9681821-2019-00035
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• PMA/PMN Number: 20-986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 04/17/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 185490
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR
• Patient Weight: 90